FDA Product Code HQC: Unit, Phacofragmentation
Cataract surgery is the most commonly performed ophthalmic procedure worldwide. FDA product code HQC covers phacofragmentation units used to emulsify and aspirate the cataractous lens.
These systems use ultrasonic vibration at the tip of a needle to fragment the lens nucleus into small pieces that are simultaneously aspirated, allowing removal of the opaque lens through a small incision before intraocular lens implantation.
HQC devices are Class II medical devices, regulated under 21 CFR 886.4670 and reviewed by the FDA Ophthalmic panel.
Leading manufacturers include Alcon Laboratories, Inc., Bausch and Lomb, Incorporated and Carl Zeiss Meditec Cataract Technology, Inc..
FDA 510(k) Cleared Unit, Phacofragmentation Devices (Product Code HQC)
About Product Code HQC - Regulatory Context
510(k) Submission Activity
315 total 510(k) submissions under product code HQC since 1977, with 315 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under HQC have taken an average of 248 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
HQC devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →